Bifurcated highly conformable medical device branch access

ABSTRACT

The present invention comprises a highly conformable stent graft with an optional portal for a side branch device. Said stent graft comprises a graft being supported by a stent, wherein said stent comprises undulations each which comprise apices in opposing first and second directions and a tape member attached to said stent and to said graft such that the tape member edge is aligned to the edge of the apices in the first direction of the each of the undulations, thus confining the apices in the first direction of the undulations to the graft and wherein the apices in the second direction of the undulation are not confined relative to the graft; wherein said graft forms unidirectional pleats where longitudinally compressed and wherein said apices in the first direction of said undulation is positioned under an adjacent pleat when compressed. The invention also discloses and claims methods of making and using said highly conformable stent graft and method of making the optional portal.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit to U.S. Provisional Patent ApplicationSer. No. 61/250,313 filed Oct. 9, 2009, which is incorporated byreference herein for all purposes

FIELD OF THE INVENTION

One aspect of the invention is directed to an improved, modular,bifurcated stent graft having an integral support tube. Another aspectof the invention is directed to a highly conformable stent graft with anoptional bifurcation.

BACKGROUND

Aneurysms occur in blood vessels at sites where, due to age, disease orgenetic predisposition of the patient, the strength or resilience of thevessel wall is insufficient to prevent ballooning or stretching of thewall as blood passes through. If the aneurysm is left untreated, theblood vessel wall may expand and rupture, often resulting in death.

To prevent rupturing of an aneurysm, a stent graft may be introducedinto a blood vessel percutaneously and deployed to span the aneurysmalsac. Stent grafts include a graft fabric secured to a cylindricalscaffolding or framework of one or more stents. The stent(s) providerigidity and structure to hold the graft open in a tubular configurationas well as the outward radial force needed to create a seal between thegraft and a healthy portion of the vessel wall and provide migrationresistance. Blood flowing through the vessel can be channeled throughthe luminal surface of the stent graft to reduce, if not eliminate, thestress on the vessel wall at the location of the aneurysmal sac. Stentgrafts may reduce the risk of rupture of the blood vessel wall at theaneurysmal site and allow blood to flow through the vessel withoutinterruption.

However, various endovascular repair procedures such as the exclusion ofan aneurysm require a stent graft to be implanted adjacent to a vascularbifurcation. Often the aneurysm extends into the bifurcation requiringthe stent graft to be placed into the bifurcation. A bifurcated stentgraft is therefore required in these cases. Modular stent grafts, havinga separate main body and branch component are often preferred in theseprocedures due to the ease and accuracy of deployment. See U.S. PatentApplication No. 2008/0114446 to Hartley et al. for an example of amodular stent graft having separate main body and branch stentcomponents. In the Hartley et al. publication the main body stent has afenestration in the side wall that is tailored to engage and secure theside branch stent. The side branch stent in such a configuration is in a“line to line” interference fit with the main body fenestration, causinga potential compromise to the fatigue resistance of the stent to stentjunction. U.S. Pat. No. 6,645,242 to Quinn presents a more robust stentto stent joining configuration. In the Quinn patent, a tubular support,internal to the main body stent, is incorporated to enhance thereliability of the stent to stent joining. The tubular, internal supportof Quinn provides an extended sealing length along with improved fatigueresistance. However, the innermost tube is made by adding additionalmaterial shaped into a tube and sewn and/or adhered to the main graftcomponent.

In addition, Aneurysms occurring in the aorta, the largest artery in thehuman body, may occur in the chest (thoracic aortic aneurysm) or in theabdomen (abdominal aortic aneurysm). Due to the curvature of the aorticarch, thoracic aortic aneurysms can be particularly challenging totreat. Other parts of the vasculature, such as the common iliac arterywhich extends from the aorta, can also be extremely tortuous. Hence, astent graft deployed into such regions is preferably able to conform tothe vasculature. The high degree of conformability allows the stentgraft to bend and optimally oppose and seal against the native vessel.

SUMMARY OF THE INVENTION

The one embodiment of the invention is directed to an improved, modular,bifurcated stent graft having an integral support tube. In anotherembodiment, the invention is directed to a highly conformable stentgraft with or without at least one portal for a side branch device (e.g.a stent graft).

One embodiment of the invention comprises a multi-lumen stent graftcomprising: a primary lumen defined by a graft composed of an innermosttube with an opening and an outermost tube with an opening, said graftbeing supported by a primary stent; and a secondary lumen disposedbetween the innermost tube and outermost tube of said graft, whereinsaid secondary lumen is in fluid communication through said openings. Inone embodiment, said secondary lumen comprises a secondary stent orstent assembly. In another embodiment, said secondary lumen can acceptanother smaller stent graft.

Another embodiment of the invention comprises a stent graft forimplantation in a bifurcated body lumen having a main branch vessel anda side branch vessel, wherein the stent graft comprises: a graft, saidgraft composed of an innermost tube with an opening and an outermosttube with an opening, said graft extending along a longitudinal axisfrom a distal end to a proximal end and defining a main lumen extendingtherethrough, said graft being supported by a primary stent; and asecondary lumen disposed between the innermost tube and outermost tubeof said graft, said secondary lumen portion positioned between thedistal and proximal ends of said graft, wherein said secondary lumen isin fluid communication through said openings of said innermost andoutermost tubes. In one embodiment, said primary stent is a selfexpanding stent.

Another embodiment of the invention comprises covering a first mandrelthat comprises a groove and a back wall of said groove with an innermostpolymeric tube; slitting said polymeric tube along said back wall ofsaid groove; placing a second mandrel into said groove of the firstmandrel and aligning said second mandrel with the back wall of thegroove, deforming said innermost polymeric tube; placing an outermostpolymeric tube over said inner most tube; and making an opening oversaid second smaller mandrel; wherein said outermost tube and innermosttube comprise a graft member.

Another embodiment of the invention comprises a graft being supported bya stent, wherein said stent comprise undulations each which compriseapices in opposing first and second directions, and a tape member,having first and second longitudinal edges, attached to said stent andto said graft such that the first tape edge substantially covers theapices in the first or the second direction of the each of theundulations, thus confining the apices in the first direction or seconddirection of the undulations to the graft and wherein the apices in thefirst or the second direction of the undulation are not confinedrelative to the graft. In one embodiment, said apices in the firstdirection are confined to the graft and the apices in second directionare not confined relative to the graft. In another embodiment, saidapices in the second direction apices are confined to the graft and theapices in the first direction are not confined relative to the graft. Inanother embodiment, said graft forms circumferentially orientedunidirectional pleats where longitudinally compressed. In anotherembodiment, said apices in the first direction of said undulation arepositioned under an adjacent pleat where compressed. In anotherembodiment, said stent is formed from a single continuous wire helicalwrapped around said graft. In another embodiment, said stent is aself-expanding stent. In another embodiment, said stent is made fromNitinol. In another embodiment, said undulations have a sinusoidalshape. In another embodiment, said graft comprisespolytetrafluoroethylene.

Additional features and advantages of the invention will be set forth inthe description or may be learned by practice of the invention. Thesefeatures and other advantages of the invention will be realized andattained by the structure particularly pointed out in the writtendescription and claims hereof as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the invention and are incorporated in and constitute apart of this specification, illustrate embodiments of the invention andtogether with the description serve to explain the principles of theinvention.

In the drawings:

FIG. 1A is a perspective view of a modular, bifurcated stent grafthaving a main body stent, an internal support tube and attached sidebranch stent. FIGS. 1B, 1C, 1D and 1E comprise a bifurcated stent graft,in which the main body comprises at least one side branch portal madefrom a portion of the main body graft.

FIGS. 2A and 2B depict perspective views of a mandrel used to constructa main body stent graft having an integral support tube.

FIGS. 3A and 3B depict perspective views of a mandrel used to constructa main body stent graft having an integral support tube and a secondarystent assembly.

FIGS. 4A and 4B depict schematic side views of a mandrel used toconstruct a main body stent graft having an integral support tube and asecondary stent assembly.

FIGS. 5A, 5B, 5C and 5D are side views of a mandrel and stentfabrication process.

FIG. 6 is a top view of a bifurcated stent graft with a side branchportal.

FIG. 7 is a perspective view of a side branch stent having three purposebuilt portions.

FIG. 8 depicts a fully extended stent graft.

FIG. 9 depicts a flexible stent graft in a state of full longitudinalcompression, wherein the unidirectional pleats are formed around thefull circumference of the stent graft.

FIGS. 10A and B depict a partial cross-sectional view of one wall of thestent graft, taken along cross-sectional plane 3-3 of FIG. 8,illustrating the unidirectional pleating of the compressed stent graft.

FIG. 11 depicts a flexible stent graft a state of partial longitudinalcompression (or in a bent shape), wherein the unidirectional pleats areformed on a portion of the stent graft circumference (or on the innermeridian) and the outer meridian has un-pleated or straight graftportions.

FIG. 12 depicts a “flat or unrolled” drawing of the cylindrical mandrel.

FIG. 13 depicts a single circumference winding pattern.

FIG. 14 depicts a stent graft having an undulating, helical wire stentsurrounding a graft material. The stent is attached to the graftmaterial by a helical a tape member.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

One embodiment of the invention is directed to an improved, modular,bifurcated stent graft having an integral support tube. In anotherembodiment, the invention is directed to a highly conformable stentgraft with or without at least one portal for a side branch device (e.g.a stent graft).

In general, most bifurcated stent grafts have an internal tube to createthe bifurcation or a fenestration on the side of a stent graft in whichanother tube or stent graft is inserted. See, for example U.S. Pat. No.6,645,242 to Quinn and U.S. Pat. No. 6,077,296 to Shokoohi. FIG. 1 is aperspective view of a general modular bifurcated stent graft 100 havinga main body 102 with an internal tube 104. In general, most internaltubes (i.e. bifurcation tubes) are made by adding additional materialthat is formed into a tube or a bifurcation site and sewn and/or adheredto the internal side of the main body (usually the graft). The internaltube 104 is sized to engage and secure a side branch device 106, shownprotruding from a main body portal 108. The main body 102 is shownimplanted into a main vessel 110 with the side branch stent implantedinto a branch vessel 112. The instant invention, as depicted in FIGS. 1Bto 7, comprises a bifurcated stent graft, in which the main bodycomprises at least one side branch portal made from a portion of themain body graft wherein said at least a portion of said portal isintegral with said graft and which at least a portion of said portal hasno seams in the main blood flow surface of the graft and/or weakenedareas due to non-continuous construction.

One embodiment of the invention is shown in FIGS. 1B to 1D. FIG. 1B is atop view of a bifurcated stent graft 120 having a primary stent (or mainbody stent) 122 with a side branch portal 124. Also depicted is a stentfeature 121 which creates an area for the side branch portal. In thisembodiment, said feature is called the “double W”. In this embodiment,said “double W” helps support the side branch portal and prevents saidportal from collapsing. In addition, this design creates a region for aside branch portal without creating a high strain region in the bodywinding pattern of the stent. Without being bound to a particulartheory, one reason may be that the “double W” design does not rely onshorter amplitude struts that stiffen the frame and results in higherstains, which may cause fractures when the stent is stressed. The mainbody portal 124 is sized to engage and secure a side branch stent, oneembodiment of which is depicted in FIG. 7, 700.

FIG. 1C is a side view with a partial longitudinal cross section of FIG.1B. This Figure depicts primary lumen 128, a secondary lumen 130, anoutermost tube 132, an innermost tube 134 and an optional secondarystent 126. Also depicted is the innermost tube opening 131.

FIG. 1D is a cross section of A-A in FIG. 1C. This Figure depictsprimary stent 122, secondary stent 126, primary lumen 128, and secondarylumen 130. This Figure also depicts an outermost tube 132 and aninnermost tube 134.

FIG. 1E is a close up of section D depicted on FIG. 1D. Thus, thisFigure is a close up of the cross section of the side branch portal.This Figure depicts the primary stent 122, secondary stent 126, andsecondary lumen 130. This Figure also depicts an outermost tube 132 andan innermost tube 134. Graft 136 is composed of innermost tube 134 andoutermost tube 132. Also depicted is the blood flow surface 138 (i.e.the internal graft surface), the outer surface of the innermost tube 140and the inner surface of the outermost tube 141.

Thus, one embodiment of the invention, the bifurcated (multi-lumen)stent graft, comprises a primary lumen 128 defined by a graft 136composed of an innermost tube 134 with an opening 131 and an outermosttube 132 with an opening 124, said graft being supported by a primarystent 122; and a secondary lumen 130 disposed between the innermost tube132 and outermost tube 134 of said graft 136; wherein said secondarylumen is in fluid communication through said openings 131 and 124. Inone embodiment, said secondary lumen 130 comprises a secondary stent 126or stent assembly. As used herein, said secondary stent assembly is asecondary stent that is covered and may comprise additional featuressuch as radiopaque markers. In another embodiment, said secondary lumenis disposed between the ends of the main stent graft or main body. Inanother embodiment, a portion of the said secondary stent or stentassembly abuts against a portion of the innermost tube 134. In anotherembodiment, said secondary stent or stent assembly abuts against aportion of graft 136. In another embodiment, a portion of said secondarystent or stent assembly lays on the outer surface of the innermost tube140. In another embodiment, said secondary lumen is defined partially bythe innermost tube and partially by the outermost tube. In anotherembodiment, said secondary lumen is defined partially by the outersurface of the innermost tube 140 and the inner surface of the outermosttube 141.

The graft of the stent graft of the invention may be made up of anymaterial which is suitable for use as a graft in the chosen body lumen.Said graft can be composed of the same or different materials.Furthermore, said graft can comprise multiple layers of material thatcan be the same material or different material. Although the graft canhave several layers of material, said graft may have a layer that isformed into a tube (innermost tube) and an outermost layer that isformed into a tube (outermost tube). For the purposes on this invention,the outermost tube does not comprise a tape layer that may be used toadhere a stent to a graft as described in more detail below. In oneembodiment of the invention, said graft comprises an innermost tube andan outermost tube.

Many graft materials are known, particularly known are those that can beused as vascular graft materials. In one embodiment, said materials canbe used in combination and assembled together to comprise a graft. Thegraft materials used in a stent graft can be extruded, coated or formedfrom wrapped films, or a combination thereof. Polymers, biodegradableand natural materials can be used for specific applications.

Examples of synthetic polymers include, but are not limited to, nylon,polyacrylamide, polycarbonate, polyformaldehyde, polymethylmethacrylate,polytetrafluoroethylene, polytrifluorochlorethylene, polyvinylchloride,polyurethane, elastomeric organosilicon polymers, polyethylene,polypropylene, polyurethane, polyglycolic acid, polyesters, polyamides,their mixtures, blends and copolymers are suitable as a graft material.In one embodiment, said graft is made from a class of polyesters such aspolyethylene terephthalate including DACRON® and MYLAR® and polyaramidssuch as KEVLAR®, polyfluorocarbons such as polytetrafluoroethylene(PTFE) with and without copolymerized hexafluoropropylene (TEFLON® orGORE-TEX®), and porous or nonporous polyurethanes. In anotherembodiment, said graft comprises expanded fluorocarbon polymers(especially PTFE) materials described in British. Pat. Nos. 1,355,373;1,506,432; or 1,506,432 or in U.S. Pat. Nos. 3,953,566; 4,187,390; or5,276,276, the entirety of which are incorporated by reference. Includedin the class of preferred fluoropolymers are polytetrafluoroethylene(PTFE), fluorinated ethylene propylene (FEP), copolymers oftetrafluoroethylene (TFE) and perfluoro (propyl vinyl ether) (PFA),homopolymers of polychlorotrifluoroethylene (PCTFE), and its copolymerswith TFE, ethylene-chlorotrifluoroethylene (ECTFE), copolymers ofethylene-tetrafluoroethylene (ETFE), polyvinylidene fluoride (PVDF), andpolyvinyfluoride (PVF). Especially preferred, because of its widespreaduse in vascular prostheses, is ePTFE. In another embodiment, said graftcomprises a combination of said materials listed above. In anotherembodiment, said graft is substantially impermeable to bodily fluids.Said substantially impermeable graft can be made from materials that aresubstantially impermeable to bodily fluids or can be constructed frompermeable materials treated or manufactured to be substantiallyimpermeable to bodily fluids (e.g. by layering different types ofmaterials described above or known in the art). In another embodiment,said outermost tube comprises ePTFE. In another embodiment, saidinnermost tube comprises ePTFE. In another embodiment, said innermostand outermost tube comprises ePTFE film that has been wrapped into atube. In another embodiment, said secondary stent is covered with any ofthe material disclosed herein or known in the art. In anotherembodiment, the secondary stent covering comprises ePTFE.

Additional examples of graft materials include, but are not limited to,vinylidinefluoride/hexafluoropropylene hexafluoropropylene (HFP),tetrafluoroethylene (TFE), vinylidenefluoride,1-hydropentafluoropropylene, perfluoro (methyl vinyl ether),chlorotrifluoroethylene (CTFE), pentafluoropropene, trifluoroethylene,hexafluoroacetone, hexafluoroisobutylene, fluorinatedpoly(ethylene-co-propylene (FPEP), poly(hexafluoropropene) (PHFP),poly(chlorotrifluoroethylene) (PCTFE), poly(vinylidene fluoride (PVDF),poly(vinylidene fluoride-co-tetrafluoroethylene) (PVDF-TFE),poly(vinylidene fluoride-co-hexafluoropropene) (PVDF-HFP),poly(tetrafluoroethylene-co-hexafluoropropene) (PTFE-HFP),poly(tetrafluoroethylene-co-vinyl alcohol) (PTFE-VAL),poly(tetrafluoroethylene-co-vinyl acetate) (PTFE-VAC),poly(tetrafluoroethylene-co-propene) (PTFEP)poly(hexafluoropropene-co-vinyl alcohol) (PHFP-VAL),poly(ethylene-co-tetrafluoroethylene) (PETFE),poly(ethylene-co-hexafluoropropene) (PEHFP), poly(vinylidenefluoride-co-chlorotrifluoroe-thylene) (PVDF-CTFE), and combinationsthereof, and additional polymers and copolymers described in U.S.Publication 2004/0063805, incorporated by reference herein in itsentirety for all purposes. Additional polyfluorocopolymers includetetrafluoroethylene (TFE)/perfluoroalkylvinylether (PAVE). PAVE can beperfluoromethylvinylether (PMVE), perfluoroethylvinylether (PEVE), orperfluoropropylvinylether (PPVE), as essentially described in U.S.Publication 2006/0198866 and U.S. Pat. No. 7,049,380, both of which areincorporated by reference herein for all purposes in their entireties.Other polymers and copolymers include, polylactide,polycaprolacton-glycolide, polyorthoesters, polyanhydrides;poly-aminoacids; polysaccharides; polyphosphazenes; poly(ether-ester)copolymers, e.g., PEO-PLLA, or blends thereof, polydimethyl-siolxane;poly(ethylene-vingylacetate); acrylate based polymers or copolymers,e.g., poly(hydroxyethyl methylmethacrylate, polyvinyl pyrrolidinone;fluorinated polymers such as polytetrafluoroethylene; cellulose estersand any polymer and copolymners described in U.S. Publication2004/0063805, incorporated by reference herein in its entity.

Said stents of the instant intention are generally cylindrical andcomprise helically arranged undulations having plurality of helicalturns. The undulations preferably are aligned so that they are“in-phase” with each other as shown in FIG. 8. More specifically,undulations comprise apices in opposing first 814 and second 816directions. When the undulations are in-phase, apices in adjacenthelical turns are aligned so that apices can be displaced intorespective apices of a corresponding undulation in an adjacent helicalturn. In one embodiment, said undulations have a sinusoidal shape. Inanother embodiment, said undulations are U shaped. In anotherembodiment, said undulations are V shaped. In another embodiment, saidundulations are ovaloid shaped. These shapes are fully described in U.S.Pat. No. 6,042,605, FIGS. 14A-E. U.S. Pat. No. 6,042,605 is incorporatedby reference herein in its entirety for all purposes.

In another embodiment of the invention, said stent can be fabricatedfrom a variety of biocompatible materials including commonly knownmaterials (or combinations of materials) used in the manufacture ofimplantable medical devices. Typical materials include 316L stainlesssteel, cobalt-chromium-nickel-molybdenum-iron alloy (“cobalt-chromium”),other cobalt alloys such as L605, tantalum, Nitinol, or otherbiocompatible metals. In one embodiment, said stent graft is a balloonexpandable stent graft. In another embodiment, said stent graft is aself-expanding stent graft. In another embodiment, said stent is a wirewound stent. In another embodiment, said wire wound stent compriseundulations.

The wire wound stent can be constructed from a reasonably high strengthmaterial, i.e., one which is resistant to plastic deformation whenstressed. In one embodiment, the stent member comprises a wire which ishelically wound around a mandrel having pins arranged thereon so thatthe helical turns and undulations can be formed simultaneously, asdescribed below. Other constructions also may be used. For example, anappropriate shape may be formed from a flat stock and wound into acylinder or a length of tubing formed into an appropriate shape or lasercutting a sheet of material. In another embodiment, said stent is madefrom a super-elastic alloy. There are a variety of disclosures in whichsuper-elastic alloys such as nitinol are used in stents. See forexample, U.S. Pat. No. 4,503,569, to Dotter; U.S. Pat. No. 4,512,338, toBalko et al.; U.S. Pat. No. 4,990,155, to Wilkoff; U.S. Pat. No.5,037,427, to Harada, et al.; U.S. Pat. No. 5,147,370, to MacNamara etal.; U.S. Pat. No. 5,211,658, to Clouse; and U.S. Pat. No. 5,221,261, toTermin et al.

A variety of materials variously metallic, super elastic alloys, such asNitinol, are suitable for use in these stents. Primary requirements ofthe materials are that they be suitably springy even when fashioned intovery thin sheets or small diameter wires. Various stainless steels whichhave been physically, chemically, and otherwise treated to produce highspringiness are suitable as are other metal alloys such as cobalt chromealloys (e.g., ELGILOY®), platinum/tungsten alloys, and especially thenickel-titanium alloys generically known as “nitinol”.

Nitinol is especially preferred because of its “super-elastic” or“pseudo-elastic” shape recovery properties, i.e., the ability towithstand a significant amount of bending and flexing and yet return toits original form without permanent deformation. These metals arecharacterized by their ability to be transformed from an austeniticcrystal structure to a stress-induced martensitic structure at certaintemperatures, and to return elastically to the austenitic shape when thestress is released. These alternating crystalline structures provide thealloy with its super-elastic properties. These alloys are well known butare described in U.S. Pat. Nos. 3,174,851; 3,351,463; and 3,753,700.

Other suitable stent materials include certain polymeric materials,particularly engineering plastics such as thermotropic liquid crystalpolymers (“LCP's”). These polymers are high molecular weight materialswhich can exist in a so-called “liquid crystalline state” where thematerial has some of the properties of a liquid (in that it can flow)but retains the long range molecular order of a crystal. The term“thermotropic” refers to the class of LCP's which are formed bytemperature adjustment. LCP's may be prepared from monomers such asp,p′-dihydroxy-polynuclear-aromatics or dicarboxy-polynuclear-aromatics.The LCP's are easily formed and retain the necessary interpolymerattraction at room temperature to act as high strength plastic artifactsas are needed as a foldable stent. They are particularly suitable whenaugmented or filled with fibers such as those of the metals or alloysdiscussed below. It is to be noted that the fibers need not be linearbut may have some preforming such as corrugations which add to thephysical torsion enhancing abilities of the composite.

Another embodiment of the invention comprises a stent graft forimplantation in a bifurcated body lumen having a main branch vessel anda side branch vessel, wherein the stent graft comprises: a graft, saidgraft composed of an innermost tube with an opening and an outermosttube with an opening, said graft extending along a longitudinal axisfrom a distal end to a proximal end and defining a main lumen extendingtherethrough, said graft being supported by a primary stent; and asecondary lumen disposed between the innermost tube and outermost tubeof said graft, said secondary lumen portion positioned between thedistal and proximal ends of said graft, said secondary lumen is in fluidcommunication through said openings of said innermost and outermosttubes. In one embodiment, said primary stent is a self expanding stent.In another embodiment, said self expanding stent comprises atitanium-nickel alloy. In another embodiment, said stent comprises asingle continuous wire helically wrapped around said graft. In anotherembodiment, wherein said single continuous wire comprises undulations.In another embodiment, said undulating wire comprises multiple turns ofsaid undulations, and each turn of said undulating wire comprisesmultiple apexes, with undulation in one turn generally in-phase withundulation in an adjacent turn. In another embodiment, said undulationsare U shaped. In another embodiment, said undulations are V shaped. Inanother embodiment, said undulations are ovaloid shaped. In anotherembodiment, said undulations are sinusoidal shaped. In anotherembodiment, said stent is attached to said graft. In another embodiment,said stent is attached to said graft by a ribbon or tape. In anotherembodiment, said ribbon or tape is adhered to a portion of said stentand a portion of said graft. In another embodiment, said ribbon or tapeis arranged in a helical configuration with multiple turns. In anotherembodiment, said ribbon or tape is arranged in a helical configurationwith multiple turns, each turn being spaced from an adjacent turn. Inanother embodiment, said spacing between said turns is uniform. Inanother embodiment, said ribbon covers a portion of said undulation. Inanother embodiment, said stent comprises undulations each which comprisean apex portion and a base portion and said ribbon or tape is attachedto said stent such that the ribbon is placed along to the base portionof the each of the undulations thus confining the base portion of theundulations to the graft and wherein the apex portion of the undulationis not confined.

At least one method of making a main body stent graft having an integralsupport tube is described in FIG. 2 through FIG. 7.

FIG. 2A is a perspective view of a metallic mandrel 200 having a slot orgroove 202 formed into one end of the mandrel. The groove 202 terminatesinto a back wall 204. As shown in perspective view FIG. 2B, an innertube 206 is slip-fit over the mandrel 200, covering a portion of themandrel groove 202. An inner tube can comprise any biocompatible polymerthat is deformable (to allow a subsequent insertion of a side branchstent) and can be extruded, coated or formed from wrapped films.Suitable materials used for the inner tube may include, but are notlimited to, any of the material described above, any other biocompatiblematerial commonly known in the art or a combination thereof.

FIG. 3A is a perspective view of the mandrel 200 covered by the innertube 206. The inner tube is cut, forming a slit 300 at the back wall 204of the mandrel groove 202. As shown in FIG. 3B, a side branch orsecondary stent assembly 302 is aligned to the mandrel groove 202,mandrel back wall 204 and inner tube slit 300. A first support segment(subsequently described) is placed into the secondary stent assembly andthe secondary stent assembly 302 (with the first support segment) isthen inserted into the mandrel groove 202, deforming the inner tube 206into the mandrel groove. The back wall 204 defines the opening in theinnermost tube (131, FIG. 1E)

To control the deformed shape of the inner tube, support segments areplaced into the secondary stent assembly and into the mandrel groove, asdepicted in FIGS. 4A and 4B. Shown in FIG. 4A is a side view schematicof the mandrel 200, the groove 202 and the groove back wall 204. Shownin FIG. 4B is a side view schematic of the mandrel 200, mandrel groove202 and inner tube 206. The secondary stent assembly 302 has been placedover a first support segment 400 having an end formed to mate to themandrel groove back wall 204. The opposing end of the first supportsegment has a tapered or angulated wall as depicted in FIG. 4B. A secondsupport segment 402 is placed into the mandrel groove 202 under theinner tube 206. The second support structure can have an angulated wallthat mates with the angulated wall of the first support structure,although it is not required for the second support structure to have anangulated wall. One of the purposes of this second support structure tokeep first support segment 400 in place during manufacturing. The innertube 206 is shown deformed into the mandrel groove 202. The inner tube206 is also shown having a tapered, beveled or angulated wall portion404 formed by the angulated wall of the support segment 400.

To further strengthen the inner tube (FIG. 3A, 206), additional sheet orfilm layers may be added onto the inner tube prior to the insertion ofthe secondary stent assembly. For example a square/rectangle shaped thinfilm sheet having a high degree of bi-axial strength may be placed ontothe inner tube 206 and aligned to the mandrel groove. The sheet can bedimensioned to be wider than the mandrel groove width and have a lengthapproximating the mandrel groove length. This strengthening layer willthen be deformed into the mandrel groove, providing additional supportto the inner tube/secondary stent assembly. Multiple strengtheninglayers may be combined to enhance the properties of the inner tube.Suitable materials used for strengthening layers may include, but arenot limited to, any of the material described above, any otherbiocompatible material commonly known in the art or a combinationthereof.

Although the above methods describe the making of a bifurcated stentgraft with only one portal, additional portals can also be made usingsimilar methods describe above. Thus, another embodiment of theinvention comprises a stent graft with at least two portals. In anotherembodiment, said stent graft of the invention comprises three, four,five, six or seven portals. Such a stent graft may be useful for, interalia, implanting a stent graft in the abdominal aorta where the renalarteries branch off. In addition, due to the stent graft of theinvention being highly conformable, see below, said stent graft of theinvention with three portals can be placed in the arch of the aortawithout blocking blood flow to the left subclavian artery, left commoncarotid artery and the bachiocephalic artery. In another embodiment,said several portals can be placed where desired longitudinally alongthe stent and/or circumferentially around the stent. A person of skillin the art can design said portals at any region in the vasculature.

At least one method of making a secondary stent assembly is outlined inFIGS. 5A through 5D. As shown in side view FIGS. 5A and 5B, a polymerictube 502 is slip-fit onto a mandrel 500. An undulating wire can beformed into a ring stent 506 by winding the wire onto a mandrel withprotruding pins. The diameters of the mandrel and pins along with thelocations of the pins dictate the final configuration of the ring stent.After the wire is wound onto the mandrel, the mandrel and wire are heattreated and quenched to set the shape of the stent. The wire is thenremoved from the mandrel. The ends of the wire are joined together witha section of polymeric heat shrink tubing, forming ring stent 506. Othermethods can be used to make the secondary stent (e.g. laser cutting).One or more of these ring stents 506 are then placed onto the polymerictube 502. Optional radiopaque marker bands 504 are then placed onto thepolymeric tube 502. The wire or metal tube used to make the secondarystent is described above. In one embodiment, said secondary stentcomprises Nitinol.

Next, as shown in FIG. 5C, one end of the polymeric tube 502 is invertedand drawn over the wire ring stents 506 and optional radiopaque markerbands 504. The mandrel, polymeric tube, ring stents and radiopaque bandsare then heat treated to bond the components together into a stentassembly. The assembly is removed from the mandrel and trimmed tolength, forming a secondary stent assembly 302 as shown in FIG. 5D. Thesecondary stent assembly is then placed onto a first support segment400. Radiopaque markers include, but are not limited to gold, platinum,platinum-tungsten, palladium, platinum-iridium, rhodium, tantalum, oralloys or composites of these metals.

As previously described in FIG. 4B, the secondary stent (or secondarystent assembly) and the first support assembly are then inserted intothe mandrel groove 202, deforming the inner tube 206 into the mandrelgroove. The assembly shown in FIG. 4B is then covered with an outerpolymeric tube. As described herein, said tube can be can be extruded,coated or formed from wrapped films.

The assembly is heat treated to join the inner tube to the outer tube. Aside branch portal or opening (FIG. 1, item 108) is formed as describedabove. A primary wire stent is then formed by winding a wire onto amandrel with protruding pins. The wire is heat treated to set the shapeof the wire with a process similar to that used to form the secondarystent (FIG. 5B). The primary stent is then placed over the outerpolymeric tube and overwrapped with a polymeric film. The assembly isthen heat treated to bond the components together.

Methods of attaching a stent to a graft are known in the art. Oneembodiment comprises a coupling member that is generally a flat ribbonor tape having at least one generally flat surface. In anotherembodiment of the invention, the tape member is made from expanded PTFE(ePTFE) coated with an adhesive. In another embodiment, said adhesive isa thermoplastic adhesive. In another embodiment, said thermoplasticadhesive is fluorinated ethylene propylene (FEP). In this embodiment,the FEP-coated side faces toward and contacts the exterior surface ofthe stent and graft, thus attaching the stent to the graft. Although aparticular tape member configuration and pattern has been illustratedand described, other configuration and/or patterns may be used withoutdeparting from the scope of the present invention. Materials and methodof attaching a stent to the graft is discussed in U.S. Pat. No.6,042,602 to Martin, incorporated by reference herein for all purposes.

FIG. 6 depicts a top view of a bifurcated stent graft 120 with a sidebranch portal 124. In this embodiment, the stent graft comprises ahelically formed undulating wire primary stent 122. The primary stent122 is joined to graft 136 by a film wrapping 606, as described above.The stent has film wrapped sealing cuffs 608 on the two opposing ends ofthe stent graft assembly 120. Such methods of assembly are generallydisclosed in, for example, U.S. Pat. No. 6,042,605 issued to Martin, etal., U.S. Pat. No. 6,361,637 issued to Martin, et al. and U.S. Pat. No.6,520,986 issued to Martin, et al. incorporated by reference herein forall purposes.

A side branch stent graft would ideally have a distal portion having ahigh degree of radial stiffness to allow apposition and sealing againsta vessel wall. The side branch stent would also have a mid-portion thatis highly flexible and highly fatigue resistant to the pulsatile andcyclic loading imparted by the native vessels. The side branch stentwould also have a proximal portion that is deployed into the main bodystent. This proximal portion of the side branch stent requires a highdegree of radial stiffness in order to dock and seal properly into themain body portal.

Shown in FIG. 7 is one embodiment of a side branch stent graft 700,comprising a wire wound metallic stent 702, a graft covering 704 andradiopaque marker bands 706. The side branch stent has a distal portion708, a mid-portion 710 and a proximal portion 712. The distal portion708 has a high degree of radial stiffness to allow apposition andsealing against a branch vessel wall (FIG. 1, 112). The mid-portion 710is highly flexible and highly fatigue resistant to the pulsatile andcyclic loading imparted by the native vessels. The proximal portion 712that is deployed into the main body stent (FIG. 1, 102), has a highdegree of radial stiffness in order to dock and seal properly into themain body portal and can resist compression and remain patent if anadditional device deployment is used (e.g. an extender).

The process used to manufacture a side branch stent graft 700, can beused to fabricate the stent graft assembly (FIG. 6, 120) as definedabove. Such methods of assembly are generally disclosed in, for example,U.S. Pat. No. 6,042,605 issued to Martin, et al., U.S. Pat. No.6,361,637 issued to Martin, et al. and U.S. Pat. No. 6,520,986 issued toMartin, et al. The stiffness, radial strength, flexibility and fatiguelife of a side branch stent can be controlled by the stent wireproperties, wound pattern geometries of the wire, graft properties andwire to graft attachment configurations. For example in FIG. 7, thedistal portion 708 of the side branch stent 700 has an undulating wirepattern with relatively large undulation amplitude. The undulations arealso spaced relatively far apart. In comparison, the mid-portion 710 ofthe side branch stent has an undulating wire pattern with relativelysmall undulation amplitude. The undulations are also spaced relativelyfar apart. Finally, the proximal portion 712 that is deployed into themain body stent (FIG. 1, 102), has an undulating wire pattern withrelatively large undulation amplitude. The undulations are also spacedrelatively close to the adjacent wires.

Methods of joining the side branch stent graft to the main-stent graftare known. These include, but are not limited to friction fits, hooks,and barbs and/or raised stent apices. Additional methods are disclosedin U.S. Publication 2009/0043376 to Hamer and Zukowski, incorporated byreference herein in its entirety for all purposes.

The stent graft may be delivered percutaneously, typically through thevasculature, after having been folded to a reduced diameter. Oncereaching the intended delivery site it is expanded to form a lining onthe vessel wall. In one embodiment the stent graft is folded along itslongitudinal axis and restrained from springing open. The stent graft isthen deployed by removing the restraining mechanism, thus allowing thegraft to open against the vessel wall. The stent grafts of thisinvention are generally self-opening once deployed. If desired, aninflatable balloon catheter or similar means to ensure full opening ofthe stent graft may be used under certain circumstances. In anotherembodiment, said stent graft is a balloon expandable stent. The sidebranch can also be delivered percutaneously after having been folded toa reduced diameter.

The stent graft of the invention may comprise at least one or tworadiopaque markers, to facilitate proper positioning of the stent graftwithin the vasculature. Said radiopaque markers can be used to properlyalign the stent graft both axially and rotationally to confirm that theside portal is properly aligned. Said radio markers include, but are notlimited to gold, platinum, platinum-tungsten, palladium,platinum-iridium, rhodium, tantalum, or alloys. Alternatively, providedthat the delivery catheter design exhibits sufficient torquetransmission, the rotational orientation of the graft maybe coordinatedwith an indexed marker on the proximal end of the catheter, so that thecatheter may be rotated to appropriately align the side branch(es).Additional methods of delivering the bifurcated stent graft of theinvention and an associated side branch are disclosed in U.S.Publication 2008/0269866 to Hamer and Johnson and U.S. Publication2008/0269867 to Johnson, both of which are incorporated by referenceherein in their entirety for all purposes.

Another embodiment of the invention comprises a highly conformable stentgraft that can conform to highly tortuous sections of a native vessel.Said stent graft may optionally encompass at least one side branchportal.

Referring to FIG. 8, the highly conformable stent graft of the invention800 generally includes a graft 804, a stent 802 and a tape member (1406,FIG. 14) for coupling the stent and graft member together and is highlyconformable. Preferably, the stent and graft are coupled together sothat they are generally coaxial.

In one embodiment of the invention, the highly conformable stent graft800 has a helically formed wire stent 802 surrounding a graft 804. Thewire form stent has opposing first 814 and second 816 direction apices.The stent graft 800 has a first end portion 806 optionally comprising asealing cuff 808. Similarly, the stent graft 800 has a second endportion 810 optionally comprising a second sealing cuff 812 (folded backfor illustration purposes) and a radiopaque marker 818. As depicted inFIG. 9, the flexible stent graft 800 has unidirectional pleats 900 thatare formed upon longitudinal compression. In one embodiment, said stentgraft of the invention has at least one portal between the ends of saidstent graft of the invention for the introduction of a side branchdevice. In another embodiment, said side branch device is a stent graft.

FIG. 9 shows a flexible stent graft 800 in a state of longitudinalcompression, wherein the unidirectional pleats 900 are formed around thefull circumference of the stent graft 800.

FIG. 10A is a partial longitudinal cross-sectional view of one wall ofthe stent graft 800, taken along cross-sectional plane 3-3 of FIG. 9,illustrating the unidirectional pleating of the compressed stent graft800. The unidirectional pleats have a common orientation and are allbent in the same direction. The wire stent 802 is shown with opposingfirst directional apices 814 tucked under an adjacent folded portion ofthe graft material 804, forming a unidirectional pleat 900. The arrow1000 indicates a preferred blood flow direction as “going with thepleats” to minimize flow disruption and turbulence. FIG. 10B is a longcross-sectional view similar to that of FIG. 10A, showing unidirectionalpleats 900, along with a preferred blood flow direction 1000.

FIG. 11 shows a flexible stent graft 800 in a bent shape that impartscompression to the wall of the graft along the inner meridian of thebend (i.e. partial longitudinal compression) wherein the unidirectionalpleats 900 are formed on a portion of the stent graft circumference (orthe inner meridian). The outer meridian has un-pleated or straight graftportions 1100. The arrow 1102 indicates a preferred blood flow directionas previously shown in FIG. 10.

One embodiment of the invention comprises a graft being supported by astent, wherein said stent comprises undulations each which compriseapices in opposing first and second directions, and a tape member,having first and second longitudinal edges, attached to said stent andto said graft such that the first tape edge substantially covers theapices in the first or the second direction of the each of theundulations, thus confining the apices in the first or the seconddirection of the undulations to the graft and wherein the apices in thefirst or the second direction of the undulation are not confinedrelative to the graft. In one embodiment, said apices in the firstdirection apices are confined to the graft and the second directionapices are not confined relative to the graft. In another embodiment,said apices in the second direction apices are confined to the graft andthe first direction apices are not confined relative to the graft. Inanother embodiment, said graft forms circumferentially orientedunidirectional pleats where longitudinally compressed. In anotherembodiment, said confined apices (either in the first direction orsecond direction) of said undulation are positioned under an adjacentpleat when compressed. The term “confined apices” means that the apicesare attached to the graft by either a tape member or attached by anothermethod known in the art. In another embodiment, said confined apices arepositioned under an adjacent pleat thereby covering about 1%, about 2%,about 3%, about 4%, about 5%, about 10%, about 20%, about 30%, about40%, about 50% about 60%, about 70%, about 80% of undulation height 1312(FIG. 13) of the apices in the first direction. Depending on the methodof taping the stent to the graft, stent design, graft constructionand/or any other consideration due to the construction of the stentgraft, not all apices may be positioned under an adjacent pleat or maydiffer in the undulation height 1312 that can be positioned behind anadjacent pleat. Thus, there may be sections of the stent graft that maynot be compressible in accordance with the instant invention. Thus, inanother embodiment, only a section of the stent graft may be compressedby positioning confined apices under an adjacent pleat. In anotherembodiment, only a portion of the stent graft may be folded bypositioning confined apices under an adjacent pleat (in the innermeridian), as depicted in FIG. 11. Although the disclosed embodimentcomprises the apices in the first direction positioned behind pleats,the invention also encompasses apices in the second direction that areattached to the graft and are positioned under an adjacent pleat, whilethe apices in the first direction are not confined.

An important aspect of the invention is that the tape member, whichcomprises a first and second longitudinal edge, secures the stent memberto the graft member and covers only a portion of the stent member.Specifically, said tape member is attached to said stent and to saidgraft such that the first edge of said tape member substantially coversof the apices in the first direction of the each of the undulations,thus confining the apices in the first direction of the undulations tothe graft. In one embodiment, the first edge of said tape member isaligned to the edge of the apices in the first direction 814 of the eachof the undulations, as essentially depicted in FIG. 14. With thisconstruction when the stent graft is compressed, the graft formscircumferentially unidirectional pleats and allows said apices in thefirst direction 814 to be positioned under an adjacent pleat, as shownin FIGS. 9 and 11. The formation of said unidirectional pleats makessaid stent graft more conformable, thus giving the stent graft theability to bend, as depicted in FIG. 11. In one embodiment, said stentgraft can bend to at least 90° without kinking (i.e. maintains anessentially circular cross-section in the luminal surface). In anotherembodiment, said stent graft can bend to at least 90° without kinkingafter in-vivo deployment.

The tape member has a generally broad and/or flat surface forinterfacing with the stent and graft. This increases potential bondingsurface area between the tape member and the graft member to enhance thestructural integrity of the stent graft. The increased bonding surfacearea also facilitates minimizing the thickness of the tape member. Inaddition, the tape member is arranged in a helical configurationaccording to the embodiment illustrated in FIG. 14 (helically arrangedtape member 1406). As shown, the tape member may be constructed with aconstant width and arranged with uniform spacing between turns. Tapemember 1406 not only covers the apices in the first direction of each ofthe undulations, but also covers a portion of each undulation. Inanother embodiment, there can be several tape members on a stent graft,which serves the same function as described above. A non-limiting reasonto have several tape members on a stent graft is if there is adisruption in the stent pattern, such as changing the stent pattern tomake room for a portal for a side-branch device, as depicted in FIG. 12,1206, FIG. 14, 1408, and FIG. 1B, 121. In another embodiment, said tapemember does not overlap an adjacent row of undulating stent members whenthe stent graft is not compressed. Although the Examples and Figuresshow an embodiment wherein apices in the first direction of the each ofthe undulations are attached to the stent graft by the tape member, saidapices in the second direction may also be attached to the stent graftwhile the apices in the first direction are not attached.

It has been found that the width of the tape member can affect theflexibility of the stent graft. The wider the tape member, the lessflexible the stent graft will become. Thus, in one embodiment said tapemember covers about 10%, about 20% about 30%, about 40%, about 50%,about 60%, about 70%, about 80% of undulation height 1312 (FIG. 13). Inanother embodiment, the full width of said tape member is adhered tosaid stent and graft. In another embodiment, said tape member does notextend to or touch an adjacent row of the undulating stent members, e.g.when not compressed or partially compressed. In another embodiment, thewidth of said unidirectional pleats is the same as the width of the tapemember. Although the tape member can cover a portion of each undulation,including confining the apices in the first direction to the graft, asdiscussed above, apices in the second direction of the undulation arenot confined relative to the graft (e.g. 816 in FIG. 8). Thisconstruction allows for the formation of pleats where the stent graft iscompressed. Pleats can be fully circumferential when the stent graft iscompress longitudinally, as depicted in FIG. 9, or in the inner meridianof a bend, as depicted in FIG. 11. In another embodiment, saidunidirectional circumferential pleats are formed when initiallycompressed. In other words, no further manipulation of the stent graftis required to create said unidirectional circumferential pleats. Inanother embodiment, said unidirectional circumferential pleat are formedin-vivo when deployed. In another embodiment said pleats will be formedin the inner meridian in-vivo when said stent graft is deployed. Saidstent graft of the invention can conform, as describe above, to theaortic arch or other tortuous, curved or bent body lumen. In anotherembodiment, tape member (or separate pieces thereof) also surrounds theterminal end portions of the stent graft to secure the terminal portionsof the graft member to the support structure formed by stent member.

In another embodiment of the invention, the tape member is made fromexpanded PTFE (ePTFE) coated with an adhesive. In another embodiment,said adhesive is a thermoplastic adhesive. In another embodiment, saidthermoplastic adhesive is fluorinated ethylene propylene (FEP). In thisembodiment, the FEP-coated side faces toward and contacts the exteriorsurface of the stent and graft, thus attaching the stent to the graft.Although a particular tape member configuration and pattern has beenillustrated and described, other configuration and/or patterns may beused without departing from the scope of the present invention.

In another embodiment of the invention, said stent graft of theinvention comprises one or more radiopaque metallic fibers, such asgold, platinum, platinum-tungsten, palladium, platinum-iridium, rhodium,tantalum, or alloys or composites of these metals that may beincorporated into the device, particularly, into the graft, to allowfluoroscopic visualization of the device.

In another embodiment of the invention, said stent graft of theinvention comprises optional sealing cuffs 808 and 812 as shown in FIG.8. Said sealing cuff comprises a cuff which has a first cuff end securedto outer surface of the stent graft 800 and a second cuff end at least aportion of which is unsecured to form a flange. In this configuration,the flange forms a one-way valve that circumferentially surrounds thestent graft 800 and occludes flow around the stent graft. In oneembodiment, said sealing cuff is positioned around the first end portion806 of the stent graft 800. In another embodiment, said sealing cuff ispositioned around the second end portion 810 of the stent graft 800. Inanother embodiment, said sealing cuff is positioned around the first endportion 806 and the second end portion 810 of the stent graft 800. Inanother embodiment, sealing cuffs (808, 812) comprise a hydrophilicmaterial, preferably a hydrophilic polymer or gel-foam, which expandswhen exposed to water, such as in blood or other water-containing bodyfluids. In another embodiment, said sealing cuffs 808 and 812 cancomprise the materials described above. A description of sealing cuffsis found in U.S. Pat. No. 6,015,431, incorporated by reference herein inits entirety for all purposes.

This invention is further illustrated by the following Examples whichshould not be construed as limiting. The contents of all Figures andreferences are incorporated herein by reference.

While particular embodiments of the present invention have beenillustrated and described herein, the present invention should not belimited to such illustrations and descriptions. It should be apparentthat changes and modifications may be incorporated and embodied as partof the present invention within the scope of the following claims.

EXAMPLE 1 Construction of a Highly Conformable Stent Graft

A flexible stent graft was assembled having the general configuration asshown in FIG. 8.

The stent graft was fabricated by initially extruding and expanding atube of polytetrafluoroethylene (PTFE) to form a base tube. The basetube had a length of about 60 mm, a wall thickness of about 0.06 mm anda diameter of about 26 mm. The base tube had a substantial fibrilorientation in the longitudinal direction so that the tube wasrelatively strong in the longitudinal direction while being relativelyweak in the radial direction. The base tube was radially stretched overa mandrel having a diameter of about 31 mm.

To provide resistance to fluid permeation and to enhance the radialstrength of the base tube, a film of densified ePTFE was wrapped overthe base tube. The film was a thin, strong fluoropolymer; a particularlypreferred material for this application is a non-porous ePTFE providedwith an adhesive coating of thermoplastic fluorinated ethylene propylene(FEP), referred to hereinafter as “substantially impermeable ePTFE/FEPinsulating tape”. The FEP was oriented down against the base tube. EPTFEis well known in the medical device arts; it is generally made asdescribed by U.S. Pat. Nos. 3,953,566 and 4,187,390 to Gore. Theparticular tape described herein is slit from a substantially non-porousePTFE/FEP film having a thickness of about 0.0064 mm, an isopropylbubble point of greater than about 0.6 MPa, a Gurley No. (permeability)of greater than 60 (minute/1 square inch/100 cc); (or 60 (minute/6.45square cm/100 cc)), a density of 2.15 g/cc and a tensile strength ofabout 309 MPa in the length direction (i.e., the strongest direction).The film had a width of about 19 mm (0.75″) with four passes helicallywrapped with a pitch angle of about 86°.

To further enhance the radial strength of the base tube and to providean open structure bonding layer, an additional layer of film wasapplied. The ePTFE film had high degree strength in the longitudinaldirection and had a very open microstructure. The open microstructureenhanced the subsequent FEP/ePTFE bonding of a stent frame to the graft.The film had a thickness of about 2.5 microns (0.0001″) and a width ofabout 25.4 mm (1.0″). Eight helically wrapped layers were applied with apitch angle of about 83°.

The mandrel and wrapped films were then heat treated in an airconvection oven to bond the films together.

A stent frame was then formed by winding a Nitinol wire onto a mandrelhaving protruding pins. A “flat or unrolled” drawing of the cylindricalmandrel is shown in FIG. 12. Shown is an overall winding pattern 1200,detailing a first end portion 1202 and a second end portion 1204. Alsoshown is an optional “side branch portal” configuration 1206 that can beincorporated into the overall pattern if a branch portal is desired. Thegeneric single circumference winding pattern shown as 1206 can replacethe optional side branch pattern 1206 if desired.

Shown in FIG. 13 is a single circumference winding pattern shown as1206. The pattern includes a linear pitch 1300, a pin diameter 1302, awire diameter 1304, a wire apex angle 1306, a circumference 1308 and anapex to base half frequency 1310. The pattern shown was repeated alongthe stent length with the exception of the first and second end portionspreviously shown in FIG. 12 (1202, 1204). The optional side branchportal configuration (FIG. 12, 1206) was not incorporated.

The stent frame was formed according to the following dimensions asdefined in FIG. 13: the linear pitch 1300 was about 9.7 mm (0.383″), thepin diameter 1302 was about 1.6 mm (0.063″), the wire diameter 1304 wasabout 0.5 mm (0.0195″), the wire apex angle 1306 was about 50.4 degrees,the circumference 1308 was about 97.3 mm (3.83″) and the apex to basehalf frequency 1310 was about 5.3 mm (0.21″).

The mandrel with the wound wire was then heat treated in an airconvection oven as is commonly known in the art (e.g. see U.S. Pat. No.6,352,561 to Leopold), and then quenched in room temperature water.

The wire stent was the removed from the winding mandrel. The wire ends(shown in FIGS. 12, 1202 and 1204) were trimmed and tied together withhigh temperature fibers as shown in FIGS. 14, 1402 and 1404. Theamplitude of the nested pair is longer than the adjacent apexes so thatwhen the wires are nested the nested wires to not create an adverselyhigh strained region (see FIGS. 14, 1410 and 1412). The stent waspartially joined to the wrapped tube by melting the underlying FEPadjacent to portions of the stent wire using a soldering iron. A finallayer of an ePTFE tape, laminated with FEP, was wrapped over the wirestent according to the pattern depicted in FIG. 14 and placed in an ovento bond the film to the underlying graft, thus securing the stent to thegraft.

Shown in FIG. 14 is a stent graft 1400 having an undulating, helicalwire stent 802 surrounding a graft material 804. The stent is attachedto the graft material by a helically applied tape member 1406. As shown,the first edge of the helically applied tape member 1406 covers theopposing first apices 814 of the wire stent. An optional wrappingpattern section 1408 can be incorporated if a side branch portal isdesired. The tape 1406 was an ePTFE/FEP laminate having a width of about5.5 mm (0.215″) and a thickness of about 10 microns (0.0004″). The tapewas partially joined to the wrapped tube by melting the underlying FEPadjacent to portions of the stent wire using a soldering iron. Asacrificial compression tape was helically wrapped onto the stent graft.The compression tape was about 51 mm (2″) wide, about 0.5 mm (0.02″)thick and was wrapped with an approximate 50% overlap. An additionalsacrificial film was wrapped to assist in the subsequent heat treatmentcompression step. This film was an ePTFE tape having a longitudinalfibril/strength orientation, a thickness of about 2.5 microns (0.0001″)and a width of about 51 mm (2″). Five passes were applied with anapproximate 50% overlap between the film layers.

The assembly was then heat treated in an air convection oven to bond thefilm layers together (as essentially described in U.S. Pat. No.6,352,561 to Leopold). During this heat treat cycle, the film compresseddown against the mandrel causing the melted FEP to flow into theunderlying film layers, joining the graft layers together along with thewire stent. After cooling the sacrificial film compression layers wereremoved, the ends of the graft material were trimmed to length and thestent graft was removed from the mandrel. The resulting stent graft isdepicted in FIG. 8, with the exception of the optional sealing cuffs(FIG. 8, 806, 810).

EXAMPLE 2 Construction of a Highly Conformable Stent Graft Having anIntegral Side Branch Portal

Referring to FIGS. 2A and 2B, a metallic mandrel 200 was fabricatedhaving a slot 202 formed into one end of the mandrel. The slot 202terminates onto a back wall 204. The mandrel had a diameter of about 31mm and the slot was about 12.5 mm wide, by about 10 mm deep and about 13cm long. As shown in FIG. 2B, an inner tube 206 was radially stretchedonto the mandrel 200, covering a portion of the mandrel groove 202. Theinner tube was an extruded and expanded tube of polytetrafluoroethylene(PTFE). The inner tube had a length of about 60 mm, a wall thickness ofabout 0.06 mm and a diameter of about 26 mm. The inner tube had asubstantial fibril orientation in the longitudinal direction so that thetube was relatively strong in the longitudinal direction while beingrelatively weak in the radial direction.

As shown in FIG. 3A the mandrel 200 was covered by the inner tube 206.The inner tube was cut, forming a slit 300 at the back wall 204 of themandrel groove 202.

To further strengthen the inner tube (FIG. 3A, 206), two additionalpolymeric sheets were added onto the inner tube prior to the insertionof the secondary stent assembly. The strengthening layers were thendeformed into the mandrel groove, providing additional support to theinner tube/secondary stent assembly. The strengthening layers compriseddensified ePTFE provided with an adhesive coating of thermoplasticfluorinated ethylene propylene (FEP) referred to hereinafter as“substantially impermeable ePTFE/FEP insulating tape”. The FEP of thestrengthening layers was oriented towards the base tube. EPTFE is wellknown in the medical device arts; it is generally made as described byU.S. Pat. Nos. 3,953,566 and 4,187,390 to Gore. The particularstrengthening layers described herein were slit from a substantiallynon-porous ePTFE/FEP film having a thickness of about 0.0064 mm, anisopropyl bubble point of greater than about 0.6 MPa, a Gurley No.(permeability) of greater than 60 (minute/1 square inch/100 cc); (or 60(minute/6.45 square cm/100 cc)), a density of 2.15 g/cc and a tensilestrength of about 309 MPa in the length direction (i.e., the strongestdirection). The first strengthening layer was about 25 mm wide by about25 mm long and was centered over the mandrel slot about 15 mm from theslot back wall (towards the end of the mandrel). The secondstrengthening layer was about 25 mm wide and about 40 mm long and wascentered over the mandrel slot abutting the slot back wall 204.

As shown in FIG. 3B, a secondary stent assembly 302 was aligned to themandrel groove 202, mandrel back wall 204, strengthening layers andinner tube slit 300. A first support segment (subsequently described)was placed into the secondary stent assembly and the secondary stentassembly 302 (with the first support segment) was then inserted into themandrel groove 202, deforming the inner tube 206 (and strengtheninglayers) into the mandrel groove. The back wall 204 defined the openingin the innermost tube (130, FIG. 1E).

To control the deformed shape of the inner tube, a support segment wasplaced into the secondary stent assembly and into the mandrel groove, asdepicted in FIGS. 4A and 4B. Shown in FIG. 4A is a side view schematicof the mandrel 200, the groove 202 and the groove back wall 204. Shownin FIG. 4B is a side view schematic of the mandrel 200, mandrel groove202 and inner tube 206. The secondary stent assembly 302 was placed overa first support segment 400 having an end formed to mate to the mandrelgroove back wall 204. The opposing end of the first support segment hada tapered or angulated wall as depicted in FIG. 4B. A second supportsegment 402 was placed into the mandrel groove 202 under the inner tube206. The second support structure had flat walls and was used to hold ofthe first support structure 400 in place. The inner tube 206 is showndeformed into the mandrel groove 202. The inner tube 206 is also shownhaving a tapered, beveled or angulated wall portion 404 formed by theangulated wall of support segment 400.

A secondary stent assembly was assembled as outlined in FIGS. 5A through5D. As shown in FIGS. 5A and 5B, a polymeric tube 502 was slip-fit ontoa mandrel 500. The tube was formed from a film of the same material usedfor the strengthening layers as previously described. The film washelically wrapped onto a mandrel having a diameter of about 8 mm withthe FEP layer oriented away from the mandrel. The wrapped mandrel wasthen heat set to fuse the FEP/ePTFE layers forming a tube. An undulatingwire was formed into a ring stent 506 by winding the wire onto a mandrelwith protruding pins. The diameters of the mandrel and pins along withthe locations of the pins dictated the final configuration of the ringstent. The wire was Nitinol and had a diameter of about 0.15 mm. Theundulating stent pattern had an apex to apex length of about 5 mm. Afterthe wire was wound onto the mandrel, the mandrel and wire were heattreated and quenched in room temperature water to set the shape of thestent. The wire was then removed from the mandrel. The ends of the wirewere joined together with a section of polymeric heat shrink tubing,forming ring stent 506. Two of these ring stents 506 were then placedonto the polymeric tube 502. Radiopaque gold marker bands 504 were thenplaced onto the polymeric tube 502.

Next, as shown in FIG. 5C, one end of the polymeric tube 502 wasinverted and drawn over the wire ring stents 506 and radiopaque markerbands 504. The mandrel, polymeric tube, ring stents and radiopaque bandswere then heat treated to bond the components together into a stentassembly. The assembly was removed from the mandrel and trimmed tolength, forming a secondary stent assembly 302 as shown in FIG. 5D. Thesecondary stent assembly was then placed onto a first support segment400.

As previously described (FIG. 4B), the secondary stent (or secondarystent assembly) and the first support assembly were then inserted intothe mandrel groove 202, deforming the inner tube 206 into the mandrelgroove. A second support segment 402 was placed into the mandrel groove202 under the inner tube 206. The assembly shown in FIG. 4B was thencovered with an outer support film. The support was formed from a filmof the same material used for the strengthening layers as previouslydescribed. The film was about 30 mm wide by about 27 mm wide and wascentered over the mandrel slot about 6 mm behind the slot back wall(away from the mandrel end). The FEP layer was oriented down toward themandrel.

To provide resistance to fluid permeation and to enhance the radialstrength of the base tube, a film of densified ePTFE was wrapped overthe base tube. The film was a thin, strong fluoropolymer; a particularlypreferred material for this application is a non-porous ePTFE providedwith an adhesive coating of thermoplastic fluorinated ethylene propylene(FEP), referred to hereinafter as “substantially impermeable ePTFE/FEPinsulating tape”. The FEP was oriented down against the base tube. EPTFEis well known in the medical device arts; it is generally made asdescribed by U.S. Pat. Nos. 3,953,566 and 4,187,390 to Gore. Theparticular tape described herein is slit from a substantially non-porousePTFE/FEP film having a thickness of about 0.0064 mm, an isopropylbubble point of greater than about 0.6 MPa, a Gurley No. (permeability)of greater than 60 (minute/1 square inch/100 cc); (or 60 (minute/6.45square cm/100 cc)), a density of 2.15 g/cc and a tensile strength ofabout 309 MPa in the length direction (i.e., the strongest direction).The film had a width of about 19 mm (0.75″) with four passes helicallywrapped with a pitch angle of about 86°.

To further enhance the radial strength of the base tube and to providean open structure bonding layer, an additional layer of film wasapplied. The ePTFE film had a high degree strength in the longitudinaldirection and had a very open microstructure. The open microstructureenhanced the subsequent FEP/ePTFE bonding of a stent frame to the graft.The film had a thickness of about 2.5 microns (0.0001″) and a width ofabout 25.4 mm (1.0″). Eight helically wrapped layers were applied with apitch angle of about 83°.

The mandrel and wrapped films were then heat treated in an airconvection oven to bond the film layers together.

A stent frame was then formed by winding a Nitinol wire onto a mandrelhaving protruding pins. A “flat or unrolled” drawing of the cylindricalmandrel is shown in FIG. 12. Shown is an overall winding pattern 1200,detailing a first end portion 1202 and a second end portion 1204. Alsoshown is a “side branch portal” configuration 1206 that was incorporatedinto the overall pattern to form a branch portal.

Shown in FIG. 13 is a single circumference winding pattern shown as1206. The pattern includes a linear pitch 1300, a pin diameter 1302, awire diameter 1304, a wire apex angle 1306, a circumference 1308 and anapex to base half frequency 1310. The pattern shown was repeated alongthe stent length with the exception of the first and second end portionspreviously shown in FIG. 12 (1202, 1204). The optional side branchportal configuration (FIG. 12, 1206) was incorporated.

The stent frame was formed according to the following dimensions asdefined in FIG. 13: the linear pitch 1300 was about 9.7 mm (0.383″), thepin diameter 1302 was about 1.6 mm (0.063″), the wire diameter 1304 wasabout 0.5 mm (0.0195″), the wire apex angle 1306 was about 50.4 degrees,the circumference 1308 was about 97.3 mm (3.83″) and the apex to basehalf frequency 1310 was about 5.3 mm (0.21″).

The mandrel with the wound wire was then heat treated in an airconvection oven as is commonly known in the art and then quenched inroom temperature water.

The wire stent was the removed from the winding mandrel. The wire ends(shown in FIGS. 12, 1202 and 1204) were trimmed and tied together withhigh temperature fibers as shown in FIGS. 14, 1402 and 1404. The wirestent was then placed onto the previously film wrapped tube/mandrel. Thestent was partially joined to the wrapped tube by melting the underlyingFEP adjacent to portions of the stent wire using a soldering iron. Afinal layer of an ePTFE tape, laminated with FEP was wrapped over thewire stent according to the pattern depicted in FIG. 14.

Shown in FIG. 14 is a stent graft 1400 having an undulating, helicalwire stent 802 surrounding a graft material 804. The stent was attachedto the graft material by a helically applied tape member 1406. As shown,the first edge of the helically applied tape member 1406 covers theopposing first apices 814 of the wire stent. The wrapping patternsection 1408 was incorporated to form a side branch portal. The tape1406 was an ePTFE/FEP laminate having a width of about 5.5 mm (0.215″)and a thickness of about 10 microns (0.0004″). The tape was partiallyjoined to the wrapped tube by melting the underlying FEP adjacent toportions of the stent wire using a soldering iron. A sacrificialcompression tape was helically wrapped onto the stent graft. Thecompression tape was about 51 mm (2″) wide, about 0.5 mm (0.02″) thickand was wrapped with an approximate 50% overlap. An additionalsacrificial film was wrapped to assist in the subsequent heat treatmentcompression step. This film was an ePTFE tape having a longitudinalfibril/strength orientation, a thickness of about 2.5 microns (0.0001″)and a width of about 51 mm (2″). Five passes were applied with anapproximate 50% overlap between the film layers.

The assembly was then heat treated in an air convection oven to bond thefilm layers together. During this heat treat cycle, the film compresseddown against the mandrel causing the melted FEP to flow into theunderlying film layers, joining the graft layers together along with thewire stent. After cooling the sacrificial film compression layers wereremoved, the ends of the graft material were trimmed to length and thestent graft was removed from the mandrel. The resulting stent graft isdepicted in FIG. 8, with the exception of the optional sealing cuffs(FIG. 8, 806, 810).

It will be apparent to those skilled in the art that variousmodifications and variation can be made in the present invention withoutdeparting from the spirit or scope of the invention. Thus, it isintended that the present invention cover the modifications andvariations of this invention provided they come within the scope of theappended claims and their equivalents.

1. A stent graft comprising: a graft being supported by a stent, whereinsaid stent comprises undulations each which comprise apices in opposingfirst and second directions; and a tape member, comprising first andsecond longitudinal edges, attached to said stent and to said graft suchthat the first tape edge substantially covers the apices in the first orsecond direction of the each of the undulations, thus confining theapices in the first or second direction of the undulations to the graftand wherein the apices in the first or second direction of theundulation are not confined relative to the graft; wherein said graftforms circumferentially oriented unidirectional pleats whenlongitudinally compressed and said apices in the first or seconddirection of said undulation are positioned under an adjacent pleat whencompressed.
 2. The stent graft of claim 1, wherein said apices in thefirst direction are confined to the graft and the apices in the seconddirection are not confined relative to the graft.
 3. The stent graft ofclaim 1, wherein said apices in the second direction are confined to thegraft and the apices in the first direction are not confined relative tothe graft.
 4. The stent graft of claim 1, wherein said stent is formedfrom a single continuous wire helically wrapped around said graft. 5.The stent graft of claim 1, wherein said stent is a self-expandingstent.
 6. The stent graft of claim 1, wherein said stent is made fromNitinol.
 7. The stent graft of claim 1, wherein said stent is a balloonexpandable stent.
 8. The stent graft of claim 1, wherein saidundulations have a sinusoidal shape.
 9. The stent graft of claim 1,wherein said unidirectional pleats are formed in-vivo after deployment.10. The stent graft of claim 1, wherein said graft comprisespolytetrafluoroethylene.
 11. The stent graft of claim 10, wherein saidpolytetrafluoroethylene is expanded.
 12. The stent graft of claim 1,wherein said tape member comprises polytetrafluoroethylene.
 13. Thestent graft of claim 1, wherein said tape member further comprises athermoplastic adhesive.
 14. The stent graft of claim 13, wherein saidthermoplastic adhesive is FEP.
 15. The stent graft of claim 1, whereinsaid stent graft comprises at least one sealing cuff.
 16. The stentgraft of claim 1, wherein said stent graft comprises at least oneradiopaque marker.
 17. The stent graft of claim 1, wherein said stentgraft can bend to at least 90° without kinking in-vivo when deployed.18. The stent graft of claim 17, wherein said stent graft is placed intoa body lumen with blood flow direction going with the pleats to minimizeflow disruption and turbulence.